Frequently Asked Questions About ISO 9000

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Q: What Software is Available to help with ISO 9000 Compliance?

A: No software package, regardless of how sophisticated it is, can do the work of designing, creating and maintaining an ISO 9001 conformant quality management system. None-the less, several software packages are now available that can help automate some aspects of your quality management system. Here is an annotated list (That is still under construction!).

Broad Packages

ISO9 provides a fully automated web based solution for organizations implementing ISO 9001. Contact them at 1433 Webster Street, Oakland, CA 94612. Phone 1.866.321.4769, Fax 509.357.8673.

QMS/9000+ is an integrated suite of 23 computer software Modules which execute procedural, record keeping and reporting tasks needed to address ISO/QS-9000 requirements.

QMS/9000+ is available from John A. Keane & Associates, Inc., 273 Jefferson Road, Princeton, NJ 08540 609-924-7904 fax:609-924-1078 E-mail:

The ISO 9000 Quality System Checklist contains the materials that are needed to establish and maintain an ISO 9000 auditing program. It is formatted as a 3 ring binder/218 pages plus 2 diskettes for use with Microsoft Word 6.0 for Windows and Microsoft Excel 4.0a for Windows or later versions of Microsoft products.

The ASSESSOR for ISO 9000 The Assessor for ISO 9000 is a Windows based software tool that can help develop your own ISO 9000 road map. Determine if you really need ISO 9000, or to what classification you should be certified. The Assessor will educate you and provide a customized approach.

Global QA has released a package called the ISO 9000 USA.COM program. It is an ISO 9001:2000 Combined, Software, Consulting and Training package for the development and implementation of an ISO 9001:2000 Quality System.

iSO-Pro For Windows -- A Toolkit for ISO 9000 Certification. Using iSO-Pro, a company can learn about ISO 9000, compare their current quality position to the standard, track important project milestone dates and develop materials to support ISO compliance.

IBS offers enterprise-wide shop floor control and quality management software for ISO-9000/14000, ISO/TS-16949:2002 and FDA 21 CFR Part 11standards.  IBS is an ISO-9001 registered company.

iManage, Inc. -- Workflow management,  provides workflow management and software.

To The Point Consulting provides companies with software that complies with the new ISO 9001: 2000 standard.

 An ISO 9000:2000 Quality Manual System, from


A program called QUALIMETRIX is available from ALD USA, 320 W. 37th Street, #12A New York, NY 10018 Phone 212-594-6600


QMS/CIM is an ISO/QS-9000 compliant Virtual Factory which models a real factory with ISO/QS-9000 certification. Using the latest simulation technology, QMS/CIM enables students to interactively manage an ISO/QS-9000 compliant plant at the desktop. Planners can "test drive" different quality systems before committing real dollars. Three versions are available

A free version of CIM Quality can be downloaded from John A. Keane & Associates, Inc., 595 Ewing St. Princeton, NJ 08540 609-924-7904 fax:609-924-1078 E-mail:

Documented quality management system

Process documents are typically written using popular word processing programs that are generally available. Some specialized systems are also available.

Organizations may with to analyze their processes using process mapping before writing or revising process documentation. Process mapping software includes:

It is helpful to include flowcharts in the process documents. Flowcharting software includes:

There are some products available that provide "quick start" templates for creating quality manuals or process documents. They include:

Also see the comments on Document Control, below.

Control of Documents:

Several companies have reported success in using distributed electronic documentation systems, such as:

Purchasing Control

Control of production and service provision

Unisoft Corporation offers OneFACTORY, a computer integrated manufacturing (CIM) factory automation software suite for the electronics manufacturing industry. Contact them at: 116a Research Dr. Milford, CT 06460 Call: 1-888-486-4246, Fax: 1-888-329-4246. Or E-mail to:

Control of monitoring and measurement devices

Corrective Action

Monitoring and measurement

Many software packages to assist in Statistical Process Control (SPC) are available. They include:

Some assist with customer satisfaction measurement, such as the following: